USFDA reviews and accepts corrective and preventive action in response to form 483
Shilpa Medicare announced that the USFDA has issued an Establishment Inspection Report (EIR) for the Company's Active Pharmaceutical Ingredient (API) manufacturing facilities located at Raichur, Karnataka, India which was inspected between 12 December and 16 December 2016. The inspection has now been closed by the US FDA. The Company had submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines in response to the form 483 issued at the end of inspection. The US FDA has reviewed the CAPA and has found them acceptable.Powered by Capital Market - Live News
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